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J. R. Paugh, K. Shimabukuro, C. Yu, A. L. Nguyen; A Preliminary Study of the Efficacy of the Modified Schein Dry Eye Symptom Questionnaire in a Dry Eye Treatment Trial. Invest. Ophthalmol. Vis. Sci. 2007;48(13):6020.
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© ARVO (1962-2015); The Authors (2016-present)
A validated symptom questionnaire is vital to dry eye diagnosis and should be able to demonstrate change during a treatment trial. The purpose of the present study was to extend our previous validation effort (Paugh, IOVS, 2006, 47, ARVO E Abstract # 276) with the modified Schein questionnaire to determine whether it is effective in a dry eye treatment trial.
The six-question instrument developed by Schein and co-workers (Ophthalmol.,104:1395, 1997) was modified by adding a category of "never" for frequency and giving each of the five possible frequency responses a numerical value of 0-4. Thus the instrument provides a nearly-continuous measurement scale. 20 previously characterized dry eye subjects of mild to moderate severity were recruited for participation in this randomized, masked trial. Half were assigned to use a positive control (preservative free, buffered saline) and the remainder to use an hp-guar-containing "active" artificial tear (non-traditional preservatives), both applied a minimum of 6 drops per eye per day in both eyes for 4 weeks. Principal outcome measures were ocular surface staining and Schein score on a 0-24 scale.
9 controls and 10 test subjects completed the trial. There were no baseline differences in age, initial TBUT, worst sector stain, overall or overall stain, although both Schein score and rose bengal staining were worse in the control group (p = 0.01 for both, 2-sample t-test). After one month treatment, the control group demonstrated significant differences in the Schein score only (difference, baseline to final, p = 0.022). The hp-guar group demonstrated significant improvement for symptoms (p = 0.003), worst sector (p = 0.001) and overall (p = 0.008) corneal stain, but not for rose bengal stain (p = 0.653).
In this pilot study there appears to be a placebo effect relative to symptoms measured with the modified Schein instrument using a minimally efficacious formulation (buffered saline). However, symptom reduction was also observed with the more viscous tear, indicating that the instrument is useful in documenting true therapeutic efficacy.
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